Port and Surface Cleaning Devices and Techniques
This disclosure describes example antimicrobial compositions that may be used in combination with IV port cleansing caps, protective caps, or both. According to another implementations, the disclosure describes various cap devices that may be used in combination with the antimicrobial composition to cleanse, sanitized, and/or disinfected a surface.
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This claims priority to U.S. Provisional Patent Application No. 61/564,206 filed on Nov. 28, 2011, entitled “Medical Devices and Techniques for Antiseptic, Immunomodulatory and Antineoplastic Therapies,” which is hereby incorporated by reference in its entirety.
BACKGROUNDInfection remains a real problem in the medical industry today. Infections are often caused by contamination of intravascular (IV) lines (e.g., intravenous, intra-arterial, etc.), contamination of an injection site or blood draw site (e.g., from a vein, artery, or capillary), urinary catheters, wound sites, incision sites, and numerous other sources of infection in healthcare facilities. For example, in United States hospitals alone, central venous catheters cause an estimated 250,000 blood stream infections per year, which result substantial costs, both in terms of financial resources consumed and in patient morbidity. O'Grady, M D, et al., Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011, Center for Disease Control, Department of Health and Human Services. These numbers do not include infections caused contamination of injection sites, blood draw sites, non-venous catheters, or any of the other numerous sources of contamination in healthcare facilities. Infection is even more of a problem in developing nations, where syringes, IV lines, and other equipment routinely are used and re-used for multiple different patients.
The detailed description is set forth with reference to the accompanying figures. In the figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The use of the same reference numbers in different figures indicates similar or identical items or features.
This application describes approaches to reducing and/or preventing infections. In one aspect, the application describes example antimicrobial compositions that may be used alone or in combination with one or more medical devices to clean and/or disinfect intravascular (IV) line ports, other IV components (e.g., syringes, lumens, valves, etc.), injection sites, blood draw sites (e.g., from a vein, artery, or capillary), wound sites, incision sites, peritoneal dialysis sites, bladder or nephrostomy sites, other drainage sites, or any other site that is susceptible to infection.
EXAMPLE PORT PROTECTION AND CLEANING DEVICESThe rim 106 is designed as a “no touch rim,” which extends radially from the perimeter of the main body of the protective cap 100, thereby minimizing a likelihood that a user's fingers will come in contact with the internal surfaces of the protective cap during use. In the illustrated embodiment, the energy director 104 is disposed radially outward of an opening of the protective cap, but inward of an outer edge of the rim 106. This ensures that the portion of the rim 106 inside the energy director 104 remains sterile prior to use. The no touch rim 106 increases the likelihood that the portion of the rim 106 inside the energy director 104 remains sterile even during use. In other embodiments, the energy director may be disposed anywhere on the rim 106 (e.g., centrally as shown, at an inner perimeter of the rim proximate the opening, or at an outer perimeter of the rim).
As shown in
Also, while applicator material 108 is illustrated as being a generally cylindrical body, in other embodiments, the applicator material may take on other shapes and/or sizes. Further, the applicator material 108 may include different surface treatments (e.g., siping, slitting, etc.), surface finishes (e.g., macro-, micro-, or nano-structures, etc.), and/or contours (e.g., rounded, ribbed, protrusions, fingers, etc.).
Once disinfected, a protective cap, such as one described above, may be applied to the IV port 306 to provide a physical barrier against recontamination. The protective cap may contain a same or different antimicrobial composition or other composition. In some implementations, the protective cap may securely couple to the IV port 306 and may seal the IV port. In the event that the antimicrobial composition in the protective cap dries out over time, the protective cap may still include a residual barrier layer of EDTA or other chelating agent that will provide further defense to contamination. In other embodiments, the protective cap may simply be coated with a film or barrier layer of EDTA or other chelating agent over all or part of the interior and/or exterior surfaces of the protective cap.
If the IV port 306 is contaminated with bacteria, spores, parasites, viruses, bodily fluids, or other contaminants, the antimicrobial composition will begin to bubble or foam 402, providing a visual indicator of the contamination. The bubbling or foaming action is caused by reaction of the hydrogen peroxide with the bacteria, spores, parasites, and viruses. The hydrogen peroxide will also produce bubbles or foam in response to a Fenton reaction with the hemoglobin or platelets in the bodily fluids. The size and rate of bubble formation may be indicative of the level of contamination, giving the medical personnel a visual indication that the equipment is contaminated and may need further cleaning and/or replacement to avoid infection.
The protective cap 500 may then be applied to the IV port 306 to provide a physical barrier against recontamination, as shown in
In some embodiments, the antimicrobial composition in the cleaning cap 302 the protective cap 500, or both may include a dye or colorant that serves to further enhance the visual indication of contamination. When provided, the dye or colorant in the cleaning cap 302 may be the same or different color than that in the protective cap 500. For example, the dye or colorant may be of a color to match the color of the respective cap. In another example, the dye or colorant may be of a color to contrast with the color of the respective cap.
Additional details of example IV port cleaning and protective devices may be found in U.S. patent application Ser. No. 11/745,843, filed May 8, 2007, to Tennican, which is incorporated herein by reference.
EXAMPLE SITE PREPARATION DEVICESThe device 600 includes a housing or cap 602 sealed by a protective cover 604 (shown in broken lines in this figure to illustrate interior features of the device 600). Cap 602 may comprise and be constructed in similar form to protective caps 100 of
In some embodiments, the cap 602 may include a flexible and/or domed bottom surface 608, which may be depressed (as shown by the arrow in
The applicator material 606 in this embodiment may comprise an open cell foam material, a foam material including open cell regions and closed cell regions, a sponge material, an abrasive material, a mesh material, or any other material suitable for cleaning or disinfecting a site. In some embodiments, the applicator material may comprise polyurethane, silicon, silicon rubber, polyethylene, polypropylene, thermoplastic elastomer, or the like and mixtures thereof. Also, while applicator material 606 is illustrated as being a generally cylindrical body, in other embodiments, the applicator material may take on other shapes and/or sizes. Further, the applicator material 606 may include different surface treatments (e.g., siping, slitting, etc.), surface finishes (e.g., macro-, micro-, or nano-structures, etc.), and/or contours (e.g., rounded, ribbed, protrusions, fingers, etc.).
EXAMPLE PACKAGING OF CLEANING DEVICESAny of the various port and/or site cleaning devices described above may be packaged individually or in kits of multiple devices in a variety of packages.
The approach described in
In one specific example, the first cap device 806A (e.g., a yellow cap) may have a relatively high concentration of hydrogen peroxide, alcohol, and/or chelating agent, the second cap device 806B (e.g., a blue cap) may have lower concentration of hydrogen peroxide, alcohol, and/or chelating agent than the first cap device, and the third cap device 806C (e.g., a green cap) may have a lower concentration of hydrogen peroxide, alcohol, and/or chelating agent than the second cap device. In that case, the first cap device 806A may be used to clean the site first, followed by the second cap device 806B, and finally by the third cap device 806C. The higher concentrations of antimicrobial compositions may provide higher levels of disinfection, but may cause irritation to a patient's tissue especially if allowed to remain in contact with the tissue for a prolonged period. The approach described above may serve to provide high level disinfection using the first cap, followed by removal of the higher concentrations of antimicrobial composition by the second and third caps so as to minimize the risk of irritation of the patient's tissue.
In one example implementation, antimicrobial compositions that may be used in connection with the approaches described herein may include those described in, for example, U.S. patent application Ser. No. 12/874,188, filed Sep. 1, 2010, to Tennican et al., which is incorporated herein by reference. In that case, the antimicrobial compositions may include water (H2O), a strong and non-toxic chelating agent such a EDTA (e.g., disodium EDTA, calcium disodium EDTA, magnesium EDTA, gallium EDTA) or sodium citrate (or acids, salts, derivatives, or other forms of EDTA or sodium citrate), a short-chain monohydric alcohol (e.g., ethanol with a molecular formula of C2H5OH and an empirical formula of C2H6O), and a strong, small molecule oxidizing agent such as hydrogen peroxide (H2O2). In one specific example, the compositions may consist essentially of water, EDTA, ethanol, and hydrogen peroxide. However, in other examples, other antimicrobial compositions may be used in combination with the devices described in this application.
The antimicrobial compositions may be in a liquid form, a gel form, or a foam form, for example, and may be combined with one or more carriers or diluents, depending on the needs of a specific application. For example, in applications in which the antimicrobial composition is used as a hand sanitizer, the antimicrobial composition may be in a gel form. As another example, if the antimicrobial composition is used as a cleaning agent, a flush solution, or an irritant, the antimicrobial composition may be in a liquid form. In that case, the concentration of the various constituents may depend on, for example, a desired level of disinfection, whether the composition is being applied directly to living tissue or to a medical device, and/or to avoid irritation of tissue to which the composition will be applied directly or indirectly (e.g., via a medical device to which the composition is or was applied). In another example, a liquid form of the antimicrobial compositions may be vaporized or sprayed for application to nasal passages or other airways of a patient. In yet another example, the antimicrobial compositions may include or be combined with a lubricant (e.g., glycerin), surfactant or emulsifier (e.g., glycerol monolaurate (GML)), or the like and may be applied to a catheter, tracheal tube, scope, instrument, or other device that is to be inserted into a patient's body.
ConclusionAlthough the application describes embodiments having specific structural features and/or methodological acts, it is to be understood that the claims are not necessarily limited to the specific features or acts described. Rather, the specific features and acts are merely illustrative some embodiments that fall within the scope of the claims of the application.
Claims
1. A medical device comprising:
- a cap comprising: a cylindrical cavity, the cylindrical cavity having an opening and a flange at the opening; an outer surface configured to interface with a user; an inner surface within the cylindrical cavity; and an energy director located on the flange and extending perpendicular to the opening of the cylindrical cavity.
2. The medical device as recited in claim 1, wherein the cap is comprised of a polypropylene, a polyethylene, a copolymer material or mixtures thereof.
3. The medical device as recited in claim 1, wherein the flange is configured to extend radially from the perimeter of the cylindrical cavity.
4. The medical device as recited in claim 1, further comprising a protective cover attached to at least the energy director and covering at least a portion of the opening.
5. The medical device as recited in claim 4, further comprising a foam insert within the cylindrical cavity wherein the foam insert is maintained in a compressed state while the protective cover is attached and the foam insert is configured to extend outside the opening of the cylindrical cavity when the protective cover is removed.
6. The medical device as recited in claim 5, wherein a surface of the foam insert extending outside the opening of the cylindrical cavity comprises different surface treatments, finishes or contours.
7. The medical device as recited in claim 1, further comprising an antimicrobial agent disposed within the foam insert.
8. The medical device as recited in claim 7, wherein the antimicrobial agent comprises:
- about 5 to about 50 mg/ml of ethlyenediaminetetraacetic acid (EDTA);
- at most about 70% ethanol, by volume;
- at most about 7.5% hydrogen peroxide, by volume; and
- water.
9. The medical device as recited in claim 1, wherein the inner surface of the cylindrical cavity of the cap further comprises at least one of:
- a tapered stepped surface;
- a tapered smooth surface;
- a stepped surface;
- a snap fit flange;
- one or more threads;
- one or more internal slits; or
- a wire mechanism to aid in attachment of the cap to another object.
10. A medical device comprising:
- a cap having an inner surface with a cylindrical cavity and a flange at the opening of the cylindrical cavity to affix a protective cover; and
- a foam insert contained within the cylindrical cavity of the cap, the foam insert compressed by the affixation of the protective cover and configured to extend beyond the opening of the cylindrical cavity when the protective cover is removed.
11. The medical device as recited in claim 10, wherein the foam insert is a cylindrical shape comprising an inner open-cell layer connecting two outer closed-cell layers at the top and bottom of the cylindrical shape.
12. The medical device as recited in claim 11, wherein the inner open-cell layer of the foam insert includes an antimicrobial composition.
13. The medical device as recited in claim 12, wherein the antimicrobial composition comprises one or more of a surfactant, water, a low molecular weight alcohol, a peroxide, a peroxide generating agent or a chelating agent.
14. The medical device as recited in claim 11, wherein the outer closed-cell layer of the foam insert comprises a course texture.
15. The medical device as recited in claim 10, wherein the foam insert comprises polyurethane, silicon, silicon rubber, polyethylene, polypropylene, thermoplastic elastomer or mixtures thereof
16. The medical device as recited in claim 10, wherein the flange at the opening of the cylindrical cavity further comprises a raised ridge extending distally from the cylindrical cavity configured to fuse with the removable protective cover.
17. A cleaning and disinfecting assembly comprising:
- one or more caps, at least one cap having: an inner surface with a cylindrical cavity and a flange at the opening of the cylindrical cavity; an energy director located on the flange and extending perpendicular to the opening of the cylindrical cavity, the energy director configured to attach to a removable protective cover; and a foam insert within the cylindrical cavity of the cap, the foam insert compressed by the attachment of the removable protective cover and configured to extend beyond the opening of the cylindrical cavity when the protective cover is removed; and
- a package for storing the one or more caps, the packaging configured to allow the one or more caps to be stored separately and consecutively.
18. The device as recited in claim 17, wherein the flange at the opening of the cylindrical cavity of the cap is configured to extend radially from the perimeter of the cylindrical cavity.
19. The device as recited in claim 17, wherein the foam insert includes an antimicrobial composition, the antimicrobial composition comprises one or more of a surfactant, water, a low molecular weight alcohol, a peroxide, a peroxide generating agent or a chelating agent.
20. The device as recited in claim 17, wherein the foam insert comprises a course texture.
21. The device as recited in claim 17, wherein the cap is comprised of a polypropylene, a polyethylene, a copolymer material or mixtures thereof.
22. A method of preventing the spread of infectious agents comprising:
- identifying a surface to be cleansed, sanitized, or disinfected; and
- applying a medical applicator to the surface to thereby cleanse, sanitize or disinfect the surface, the medical applicator comprising: a cap having an inner surface with a cylindrical cavity and a flange at the opening of the cylindrical cavity; a foam insert within the cylindrical cavity of the cap, the foam insert configured to extend beyond the opening of the cylindrical cavity when the protective cover is removed; and a cleansing, antimicrobial or antiseptic agent disposed within the foam insert.
23. The method as recited in claim 22, wherein the surface to be cleaned, sanitized or disinfected is an area of human tissue or an area on a medical device.
24. The method as recited in claim 22, wherein the cleansing, antimicrobial or antiseptic agent comprises at least one of a surfactant, water, a low molecular weight alcohol, a peroxide, a peroxide-generating agent or a chelating agent.
25. The method as recited in claim 22, wherein the cap includes an energy director located on the flange and extending perpendicular to the opening of the cylindrical cavity.
Type: Application
Filed: Nov 28, 2012
Publication Date: May 30, 2013
Patent Grant number: 10238856
Applicant: HYPROTEK, INC. (Spokane, WA)
Inventor: HYPROTEK, INC. (Spokane, WA)
Application Number: 13/688,044
International Classification: A61M 39/16 (20060101); A61M 35/00 (20060101);